US FDA Starting to Grant Fast-Track Designation for Glioblastoma Treatments

Unfortunately, glioblastoma is an aggressive brain tumor that still remains difficult to treat. To this day, there is still an unmet need for treatment, with only 8.7% of patients surviving for up to two years, according to Tactical Therapeutics. However, it appears some companies are making sizable progress in helping those suffering from glioblastoma. For example, Plus Therapeutics’ stock was higher after receiving Fast Track status from the US FDA for its potential treatment. Kazia Therapeutics also just received FDA Fast Track status with its paxalisib. Companies such as WPD Pharmaceuticals just received further funding for its drug candidate targeting glioblastoma, as well. In all, some of the top companies to keep an eye on with such developments include WPD Pharmaceuticals Inc. (CSE:WBIO), Kazia Therapeutics Ltd. (NASDAQ:KZIA), Plus Therapeutics Inc. (NASDAQ:PSTV), Novocure Ltd. (NASDAQ:NVCR), and AstraZeneca PLC (NYSE:AZN).

WPD Pharmaceuticals Inc. (CSE:WBIO) BREAKING NEWS: WPD Pharmaceuticals Inc., a clinical-stage pharmaceutical company, is pleased to announce that it has received a prepayment of approximately C$705,000 (2,000,000 PLN) and approval for reimbursement of approximately C$175,000 (500,000 PLN) from the Polish National Center for Research and Development granted by the European Union, under the Smart Growth Operational Program 2014-2020, for the further development of WPD101, the Company’s drug candidate targeting glioblastoma which includes Phase I clinical studies.

The NCRD is an executive agency of the Minister of Science and Higher Education. It was established as a unit implementing tasks in the field of science, technology, and state innovation policy. The main aim of the Centre is to support the creation of innovative solutions and technologies that increase the competitiveness and innovation of the Polish economy. The approved prepayment for WPD’s continued advancements of the WPD101 drug candidate further validates its scientific development strategy and government support in doing so.

WPD is developing WPD101 which will allow GMB patients access to innovative molecular targeted therapies as an alternative to conventional treatment. The drug is currently in preclinical development and its consistent anticancer properties are demonstrated and validated in dogs with spontaneous GBM closely resembling GBM in human patients.

Overall, the results of these studies indicate the significant potential of WPD101 demonstrating the same effective treatment of GBM in humans. The Company expects Phase I clinical trials to begin in 2021.

Mariusz Olejniczak, CEO of WPD Pharmaceuticals commented, “We are very pleased to receive this second prepayment from the grant issued by the NCRD, which continues to validate our progress and development plans of WPD101. This funding provides important cashflow support and will be used for further development and upcoming Phase I clinical trials. Approval of these prepayments requires diligent work and I am proud of the project management team for their continued efforts.”

Other related developments from around the markets include:

Kazia Therapeutics Ltd. (NASDAQ:KZIA), an Australian oncology-focused biotechnology company, is pleased to announce that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Kazia’s paxalisib (formerly GDC-0084) for the treatment of malignant glioma, which includes Diffuse Intrinsic Pontine Glioma (DIPG), a rare and highly aggressive childhood brain cancer. Kazia CEO, Dr James Garner, commented, “Taken together, RPDD and ODD provide a powerful suite of incentives, opportunities, and protections for the development of paxalisib in DIPG. We look forward to seeing initial data from the ongoing phase I study in DIPG at St Jude Children’s Research Hospital during the second half of calendar 2020. In parallel, we are working closely with collaborators, advisors, and researchers to determine the best path forward for paxalisib in this devastating disease.”

Plus Therapeutics Inc. (NASDAQ:PSTV) announced that the U.S. Food and Drug Administration (FDA) has granted the Company Fast Track designation for its lead investigational drug, Rhenium NanoLiposomes for the treatment of patients with recurrent glioblastoma. As previously reported, the Company also received orphan drug designation from the FDA for RNL for the treatment of patients with glioblastoma. Fast Track designation confers several benefits to the drug development program including 1) more frequent meetings with FDA to discuss the drug's development plan, 2) more frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers, 3) eligibility for Accelerated Approval and Priority Review, if relevant criteria are met, and 4) Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA.

Novocure Ltd. (NASDAQ:NVCR) announced an expansion of its Executive Leadership Team, effective Sept. 1, 2020, intended to further solidify executive leadership in preparation for an anticipated period of significant innovation and growth and to recognize the proven senior management experience of key Novocure leaders. After eight years of service as Chief Financial Officer, Wilco Groenhuysen has been appointed to an expanded Chief Operating Officer role responsible for the general and administrative management of the company. He will also assume responsibility for the strategic and operational leadership of Novocure’s supply chain, warehousing and distribution, quality assurance and information technology operations. Mr. Groenhuysen is tasked to ensure organizational readiness in anticipation of the completion of four Phase 3 clinical trials over the next few years.

AstraZeneca PLC (NYSE:AZN) announced that it will be transferring the listing of its American Depositary Receipts (ADRs) and its US-listed debt securities from the New York Stock Exchange (NYSE) to the Nasdaq Global Select Market (Nasdaq) and Nasdaq Bond Exchange respectively. The transfers will be effective after market close on Thursday 24 September 2020. AstraZeneca ADRs and US-listed debt securities are expected to commence trading on Nasdaq from Friday 25 September 2020. The ADRs will continue to be listed under the ticker symbol “AZN”. The Company’s primary listing in the UK on the London Stock Exchange and in Sweden on Nasdaq Stockholm are unaffected by the move. Marc Dunoyer, Executive Director and Chief Financial Officer, said: “The change of stock exchange in the US will reduce overall listing cost for our equity and debt securities. Further, as a global science-led, patient-focused biopharmaceutical company, dedicated to pushing the boundaries of science to deliver life-changing medicines, we are excited to be joining many of the world’s largest and most innovative companies on Nasdaq.”

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